To determine whether pentoxifylline 400 mg (Trental 400) taken orally three times daily, in addition to ambulatory compression bandages and dressings, improves the healing rate of pure venous ulcers.
Randomised, double blind placebo controlled trial, parallel group study of factorial design, permitting the simultaneous evaluation of alternative pharmaceutical, bandaging, and dressings materials.
Leg ulcer clinics of a teaching and a district general hospital in southern Scotland.
200 patients with confirmed venous ulcers and in whom other major causal factors were excluded.
Pentoxifylline 400 mg three times daily or placebo.
Main outcome measure
Complete healing (full epithelialisation) of all ulcers on the trial leg.
Complete healing occurred in 65 of the 101 (64%) patients receiving pentoxifylline and 52 of the 99 (53%) patients receiving placebo.
The difference in the healing rates between patients taking pentoxifylline and those taking placebo did not reach statistical significance.
Key messagesLeg ulcers cost the NHS around £400 million per annum50%-75% of venous leg ulcers can be succesfully treated with dressings and compression bandages but take many months to healA drug that reduced the healing time of venous ulcers would be useful, although no agent has been proved to be effective to dateTrials with pentoxifylline, a vasoactive drug used in the treatment of peripheral vascular diseases, as an adjunct to the treatment of venous ulcers have been inconclusiveAt the 5% level, pentoxifylline had a non-significant effect on healing rates of pure venous ulcers